NCT01401075已完成4 期
Prospective Controlled Randomized Comparative Study About Quality of Life (QoL), Immunomodulation and Safety of Adjuvant Mistletoe Treatment in Patients With Gastric Carcinoma Receiving Chemotherapy After Operation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Abnoba Gmbh
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Quality of Life
研究概览
简要总结
Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •postoperative UICC stage Ib/II gastric carcinoma
- •indication for oral chemotherapy with doxifluridine
- •ECOG performance status 0 or 1
- •normal liver and kidney function
排除标准
- •inability to answer the QoL scales
- •concomitant therapy with steroids or biological response modifiers
- •individual hypersensitivity to mistletoe preparations
- •pregnancy or lactating
- •participation in another clinical trial
研究组 & 干预措施
doxifluridine
Active Comparator
oral chemotherapy with the 5-FU prodrug doxifluridine
干预措施: doxifluridine (Drug)
doxifluridine + mistletoe extract
Experimental
oral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection
干预措施: mistletoe extract (Drug)
doxifluridine + mistletoe extract
Experimental
oral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection
干预措施: doxifluridine (Drug)
结局指标
主要结局
Quality of Life
时间窗: 24 weeks
EORTC Quality of Life Questionnaires: 1. QLQ-C30 2. QLQ-STO22
次要结局
- Immunomodulation(24 weeks)
- Safety and tolerability(24 weeks)
研究者
研究点 (1)
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